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FDA clears Beckman Coulter’s DxC 500i Clinical Analyzer

Featuring FlexMode operations, the DxC 500i “prioritises” tests as per the urgency of the sample. Credit: Beckman Coulter Diagnostics / PRNewswire.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Beckman Coulter Diagnostics’ new DxC 500i Clinical Analyzer.

The integrated clinical chemistry and immunoassay analyser claims to deliver up to 800 clinical chemistry tests and 100 immunoassay tests every hour, which is crucial for making timely clinical decisions.

Featuring FlexMode operations, the DxC 500i “prioritises” tests according to the urgency of the sample.

Its “dynamic” sample handler works on managing re-runs and repeats by pulling in the new sample rack immediately when the previous one gets offloaded, enabling the optimisation of quick throughput in a “compact” footprint.

Since July 2024, the DxC 500i Clinical Analyzer has been available in nations that accept the CE mark. The system incorporates the technology of the DxC 500 AU Chemistry Analyzer, including its Six Sigma performance, within its clinical chemistry capabilities.

The DxC 500 AU features automated workflows, a broad range of assays, and “standardised” reagents.

Beckman Coulter Diagnostics chief portfolio officer Kathleen Orland said: “Innovations like the DxC 500i Clinical Analyzer enable Beckman Coulter to address the needs of networked laboratories with specific solutions for satellite or independent laboratories, as well as core laboratories.

“Beyond ensuring appropriate throughput levels for a networked lab, Beckman Coulter’s common reagents and consumables across its scalable clinical chemistry and immunoassay portfolio enables common reference ranges, offering integrated delivery networks (IDNs) strategic benefits in patient care and inventory management.”

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